Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Sulindac 200mg; Sulindac 200mg
Viatris Limited
Sulindac 200 mg
200 mg
Tablet
Active: Sulindac 200mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified talc Quinoline yellow Sodium starch glycolate Active: Sulindac 200mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified talc Quinoline yellow Sodium starch glycolate
Bottle, plastic, White HDPE bottle with red PP double wadded CRC, 50 tablets
Prescription
Prescription
ZaCh System S.p.A
ACLIN is indicated for acute or long-term use in the treatment of the following: · Osteoarthritis · Rheumatoid arthritis · Ankylosing spondylitis · Periarticular diseases such as acute painful shoulder (acute subacromial bursitis/supraspinatus tendonitis) and tenosynovitis · Acute gouty arthritis · Painful low back syndrome (low back pain, commonly referred to as lumbago).
Package - Contents - Shelf Life: Bottle, plastic, White HDPE bottle with red PP double wadded CRC - 50 tablets - 36 months from date of manufacture stored at or below 30°C
1987-09-24
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION ACLIN _SULINDAC TABLETS 100MG AND 200MG_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ACLIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ACLIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ACLIN IS USED FOR ACLIN is used to treat: Osteoarthritis Rheumatoid arthritis Ankylosing spondylitis Joint problems such as acute painful shoulder Acute gouty arthritis Painful low back syndrome (low back pain, also referred to as lumbago). ACLIN contains the active ingredient sulindac. It belongs to a group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs). It works by relieving pain, inflammation and tenderness, and promotes joint mobility. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. This medicine is not known to be addictive. BEFORE YOU TAKE ACLIN _WHEN YOU MUST NOT TAKE _ _IT_ YOU MUST NOT TAKE ACLIN: If you have an active peptic (stomach) ulcer or gastrointestinal (stomach or bowel) bleeding If you have a history of repeated gastrointestinal ulcer or bleeding If you are vomiting blood or material that looks like coffee grounds If you have bleeding from the rectum (back passage), have sticky black stools (bowel motions), or bloody diarrhoea If you have had an asthma attack, hives or itchy rash, or runny or blocked nose caused by aspirin or other NSAIDs If you recently had coronary artery bypass graft (CABG) surgery If you have severe liver problems If you have severe heart failure. Pročitajte cijeli dokument
Page 1 of 12 NEW ZEALAND DATA SHEET ACLIN 1. PRODUCT NAME ACLIN, 100 mg, 200 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg or 200 mg of sulindac. ACLIN tablets contain lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ACLIN 100 mg tablets: 8 mm flat bevelled edge orange-yellow tablet marked with “SD” over breakline “100” on one side and “α” on the other side. ACLIN 200 mg tablets: 10 mm flat bevelled edge orange-yellow tablet marked with “SD” over breakline “200” on one side and “α” on the other side. The tablet can be divided into equal doses. Sulindac is a non-steroidal anti-inflammatory indene-type compound. Sulindac is a yellow crystalline compound. It is a weak organic acid [pKa (25 C) 4.7]. It is soluble in water as the sodium salt or in buffers of pH 6 or higher but is practically insoluble in water below pH 4.5 and sparingly soluble in alcohol. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ ACLIN is indicated for acute or long-term use in the treatment of the following: Osteoarthritis Rheumatoid arthritis Ankylosing spondylitis Periarticular diseases such as acute painful shoulder (acute subacromial bursitis/supraspinatus tendonitis) and tenosynovitis Acute gouty arthritis Painful low back syndrome (low back pain, commonly referred to as lumbago). _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used. Page 2 of 12 DOSE The usual daily dosage of ACLIN is 400 mg per day. However, the dosage may be lowered depending on the response. Dosages above 400 mg per day are not recommended (see section 4.4). In acute gouty arthritis, therapy for 7 days is usually adequate. Patients on long term treatment should be reviewed regularly with regards to efficacy, risk-factors and ongoing need for treatment. METHOD OF ADMINISTRATION ACLIN should be administere Pročitajte cijeli dokument